Barrier membranes are an important adjunct to regeneration therapy aimed at restoring the form and function of the mouth. Commercially available barrier membranes are used in dental surgeries to help retain bone grafting materials, to help exclude epithelium and connective tissue from entering into sites of desired bone and ligament regeneration, or for the combination of these reasons. Whether restoring lost bone around teeth or implants, or in larger areas of the jaws affected by trauma or disease, too often there is inadequate gum tissue to cover the membranes which can lead to membrane exposure, extensive membrane contamination, and procedural failure which is unacceptable. Our data suggests that biologically activating membranes made of chitosan (a versatile, biocompatible, resorbable material used in wound bandages) with our proprietary biologic - a small and soluble heparan sulfate-rich co-activator of growth factors - hastens gingival healing over exposed membranes in the mouth. R&D for this project is directed at development of a bioactivated chitosan regenerative membrane that is highly effective in maintaining gingival health and integrity where membranes are unavoidably exposed to the oral environment after placement, thereby promoting more predictable outcomes for a wider range of regenerative procedures in the mouth. R&D for this project falls along three lines: biologic development, membrane development, and in vivo testing. More specifically, we will 1) advance the prototype biologic used in phase 1 studies, 2) advance our chitosan membrane formulations to incorporate bioactivation with the most clinically appropriate handling characteristics, and 3) test the product candidates in animal models for efficacy. Toxicology and safety testing will be performed with the goal of having product candidate(s) ready for human clinical trials by the end of this phase 2 project. We expect this technology to improve success rates of oral bone regenerative procedures to treat periodontal disease, to place dental implants, and in cases where maxillofacial reconstruction is needed, therefore meeting patient needs and commercial needs in a large market. There is an absence in today's standard of care for bioactivated regenerative membranes and this proposed technology addresses that need with a rationally designed R&D plan with an understanding of the existing market, competitors, or potential partners. PUBLIC HEALTH RELEVANCE: Agenta is developing biologically enhanced regenerative membranes that are used in surgical procedures such as bone grafting. Bone regeneration is often necessary and critical to successful restoration of form and function in the mouth, and procedures called guided tissue regeneration using barrier membranes are essential to achieving optimal results. Whether restoring lost bone around teeth or implants, or in larger areas of the jaws affected by trauma or disease, too often there is inadequate gum tissue to cover the membranes and the graft sites which can lead to membrane exposure and procedural failure. Our data suggests that augmenting membranes made of chitosan (an excellent biodegradable material used in wound bandages) with our proprietary biologic improves gingival healing over exposed membranes in the mouth. Chitosan is a versatile, biocompatible, resorbable matrix with hemostatic and antimicrobial properties. Our goal is to provide chitosan with the additional biological advantage of enhancing wound closure with our proposed technology. We expect this technology to improve success rates of oral bone regenerative procedures to treat periodontal disease, to place dental implants, and in cases where maxillofacial reconstruction is needed, therefore meeting patient needs and commercial needs in a large market. There is an absence in today's standard of care for bioactivated regenerative membranes and this proposed technology addresses that need with a rationally designed R&D plan with an understanding of the existing market, competitors, or potential partners.